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EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer

Breast Carcinoma Clinical Trial

Official title:
Cool Down With EMBr: Enhancing Menopausal Hot Flash Symptom Reduction After Breast Cancer

Clinical Trial Summary

This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes. SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer. II. To identify in what ways EMBr Wave has the greatest potential efficacy, such as reduction in vasomotor symptoms (VMS) severity, frequency, duration, sense of control, or self-esteem. III. To estimate effect sizes to inform power calculations for a future phase III trial. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. ARM B: Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05086705
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date October 7, 2020
Completion date December 31, 2024
View Details
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